Meningitis Outbreak: Feds Raid Compounding Pharmacy

by Michael Smith Michael Smith North American Correspondent, MedPage Today
October 16, 2012

The CDC is reporting 19 additional cases of fungal meningitis associated with a contaminated steroid made by the New England Compounding Center (NECC) in Framingham, Mass.

Moreover, late Tuesday U.S. Attorney Carmen Ortiz said federal agents raided the NECC.

Ortiz declined to offer more details on the raid, but did release this statement: "I can confirm that this office and our law enforcement partners are investigating allegations concerning the New England Compounding Center."

The new cases reported by the agency include two cases of septic arthritis associated with the steroid, and the CDC has issued an updated clinical guidance for doctors treating such cases.

The 19 new cases bring the total in the outbreak to 233 with 15 deaths in 15 states. The contaminated steroid, three lots of preservative-free methylprednisolone acetate, was shipped to pain clinics in 23 states.

The FDA said Monday it was investigating one case of possible meningitis associated with an epidural injection of triamcinolone acetonide made by NECC and two cases of fungal infection in transplant patients who were given cardioplegic solution made by the company. The solution is used to paralyze the cardiac muscle during open-heart surgery.

The transplant investigation has now been reduced to a single case, the agency said on its website Tuesday. There were no further details.

The new cases reported by the CDC include six more in Tennessee – the hardest-hit state – bringing the total there to 59.

Two more cases were also reported in Florida, Indiana, New Hampshire, New Jersey, and Ohio, as well as new single cases in Maryland, Michigan, and Virginia.

Seven states are now reporting double-digit caseloads. After Tennessee, they are Michigan with 47, Virginia with 35, Indiana with 30, Maryland with 16, Florida with 12, and New Jersey with 10.

As a first step in treating the septic arthritis seen in two of the new cases, the agency said, physicians should collect synovial fluid and/or tissue and send samples for fungal culture, molecular testing, and histopathological examination, as well as standard tests for bacterial infection and crystal-induced disease.

Until those studies are complete, doctors may use routine empiric antibacterial therapy if they think it appropriate.

If the patient is stable, -- and the doctor thinks it's safe – it may be "reasonable" to wait 2 or 3 days before starting empiric antifungal therapy in order to allow time for identification of alternative diagnoses, such as crystal-induced arthritis.

Empiric antifungal therapy, the CDC suggests, should start with oral voriconazole (VFEND), beginning with a loading dose of 6 mg/kg every 12 hours for two doses, followed by 4 mg/kg every 12 hours for the duration of treatment.

In severe cases or where there is clinical instability, intravenous voriconazole can be used, the agency suggests.

The antifungal may change when the etiology of the disease is identified, the CDC says.

In severe or clinically unstable cases, the agency says doctors should also consider adding a lipid formulation of amphotericin B, delivered intravenously at a dose of 5 mg/kg daily.

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